Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma
NCT ID: NCT01420159
Last Updated: 2012-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2011-08-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Methoxyflurane
Methoxyflurane
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Normal Saline
Methoxyflurane
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Interventions
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Methoxyflurane
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
* Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.
Exclusion Criteria
* Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
* Unable to provide written informed consent.
* Known pregnancy or lactation
* Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
* Treatment with any analgesic agent within 5 hours prior to presentation to ED (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ED).
* Current ongoing use of analgesics for chronic pain.
* Use of an investigational product within one month prior to presentation to ED.
* Known personal or familial hypersensitivity to fluorinated anaesthetics.
* Known personal or familial history of malignant hyperthermia.
* Clinically significant respiratory depression.
* Use of methoxyflurane in the previous 4 weeks.
* Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician.
* Clinically significant cardiovascular instability.
12 Years
ALL
No
Sponsors
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ORION Clinical Services
INDUSTRY
Medical Developments International Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Frank M Coffey
Role: PRINCIPAL_INVESTIGATOR
Nottingham University Hospitals, Queen's Medical Centre Campus
Locations
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Barnsley District General Hospital
Barnsley, , United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, , United Kingdom
Colchester General Hospital
Colchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus
Nottingham, , United Kingdom
Countries
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References
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Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019.
Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.
Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.
Other Identifiers
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MEOF-001
Identifier Type: -
Identifier Source: org_study_id